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临床试验/NCT03899974
NCT03899974已完成不适用

Metabolic Effects of High-amylose Wheat-based Breads in Overweight Individuals

Federico II University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
2-hours blood glucose response

研究概览

简要总结

The amylose-amylopectin ratio influences starch properties. A higher amylose content is associated with slower starch digestion thus reducing the postprandial plasma glucose response and improving the overall postprandial metabolism. So far, limited evidence is available on the metabolic effect of wheat-based foods rich in amylose. This randomised controlled study investigated the acute metabolic effects of amylose-rich wheat-based breads in overweight subjects focusing on potential mechanisms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight/obese
  • 18-70 years

排除标准

  • age <18 and >70 years;
  • fasting triglycerides ≥400 mg/dl;
  • fasting cholesterol >270 mg/dl;
  • cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study
  • established diabetes mellitus or any chronic disease
  • renal and liver failure (creatinine >1.7 mg/dl and transaminases >2 times than normal values, respectively)
  • anaemia (Hb <12 g /dl)

结局指标

主要结局

2-hours blood glucose response

时间窗: over 2 hours after the test meal

incremental area under the curve

次要结局

  • 2-hours blood insulin response(over 2 hours after the test meal)
  • 4-hours blood glucose response(over 4 hours after the test meal)
  • 4-hours blood insulin response(over 4 hours after the test meal)
  • glucose response(over 2 hours after the standard meal)
  • intestinal fermentation(over 4 hours after the test meal)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

rivellese angela

Full Professor

Federico II University

研究点 (2)

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